RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.

PURPOSE: This randomized phase III trial is studying two different methods of radiation and their side effects and comparing how well they work in treating endometrial and cervical cancer after surgery.

Validation of EPIC Bowel and Urinary domains [ Time Frame: Before study start, Week 3 of RT, Week 5 of RT, 4-6 Weeks after RT, 1 year from start of RT and 3 years from start of RT ] [ Designated as safety issue: No ]

Toxicity, as measured by CTCAE v. 4.0 [ Time Frame: Before study start, Week 5 of RT, 4-6 Weeks after RT, 1 year from start of RT and 3 years from start of RT ] [ Designated as safety issue: Yes ]

Urinary toxicity, as measured by EPIC urinary domain [ Time Frame: Before study start, Week 3 of RT, Week 5 of RT, 4-6 Weeks after RT, 1 year from start of RT and 3 years from start of RT ] [ Designated as safety issue: Yes ]

Quality of life, as measured by the FACT-G with cervix subscale [ Time Frame: Before study start, Week 5 of RT, 4-6 Weeks after RT, 1 year from start of RT and 3 years from start of RT ] [ Designated as safety issue: No ]

Health utilities, as measured by EQ-5D [ Time Frame: Before study start, Week 5 of RT, 4-6 Weeks after RT, 1 year from start of RT and 3 years from start of RT ] [ Designated as safety issue: No ]

Local-regional control [ Time Frame: End of Study ] [ Designated as safety issue: No ]

Disease-free survival [ Time Frame: End of Study ] [ Designated as safety issue: No ]

Overall survival [ Time Frame: End of Study ] [ Designated as safety issue: No ]

Identification of molecular predictors of radiation toxicity and novel circulating cancer biomarkers [ Time Frame: End of Study ] [ Designated as safety issue: No ]

Some patients receive cisplatin IV over 1 hour on day 1. Treatment continues weekly for 5 weeks, concurrently with radiation therapy, in the absence of unacceptable toxicity or disease progression.

Tissue and blood samples may be collected for biomarker and correlative analysis.

Quality of life may be assessed by questionnaires (including the Expanded Prostate Cancer Index Composite [EPIC], the Functional Assessment of Cancer Therapy-General [FACT-G, Version 4], the EQ-5D, and the Common Toxicity Criteria Adverse Events - Patient-Reported Outcome [PRO-CTCAE]) instruments at baseline and periodically during and after study therapy.

After completion of study therapy, patients are followed every 6 months for the first 2 years and then annually for 5 years.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Female

Accepts Healthy Volunteers:

No

Criteria

DISEASE CHARACTERISTICS:

Pathologically proven diagnosis of endometrial or cervical cancer

Patients must have undergone a hysterectomy (total abdominal hysterectomy, vaginal hysterectomy or radical hysterectomy, or total laparoscopic hysterectomy) for carcinoma of the cervix or endometrium within 49 days prior to registration

Performance of a bilateral salpingo-oophorectomy will be at the treating surgeon's discretion

No positive or close (< 3 mm) resection margins

Appropriate stage for protocol entry, including no distant metastases, based upon the following minimum diagnostic workup:

History/physical examination within 45 days prior to registration

Computed tomography (CT), magnetic resonance imaging (MRI), or positron emission tomography (PET)-CT including the abdomen and pelvis should be performed for initial radiological staging (performed pre- or post-surgery within 90 days prior to registration)

Imaging performed postoperatively should show no evidence of residual disease

Any evidence of malignancy identified on preoperative imaging should have been completely resected surgically prior to protocol treatment

Chest x-ray or chest CT must be performed within 90 days prior to registration (unless a PET-CT has been performed)

Endometrial cancer:

Patients with the following histologic features are eligible for pelvic radiation therapy without weekly cisplatin:

Patients with the following histologic features may be treated with pelvic radiation with or without weekly cisplatin (the decision to add weekly cisplatin for these patients is at the treating physician's discretion):

Patients with the following pathology findings may be treated with pelvic radiation with or without weekly cisplatin at the treating physician's discretion:

Patients with intermediate-risk features including two of the following histologic findings after radical hysterectomy: 1/3 or more stromal invasion, lymph-vascular space invasion or large clinical tumor diameter (> 4 cm)

Patients with cervical cancer treated with a simple hysterectomy with negative margins

Patients with any of the following criteria following radical hysterectomy are eligible for this study and must receive weekly cisplatin:

Positive resected pelvic nodes and para-aortic nodes negative if removed. NOTE: If para-aortic nodes are not removed, CT abdomen or PET CT must demonstrate no evidence of lymphadenopathy.

Microscopic parametrial invasion with negative margins

No patients with para-aortic nodal disease or who require extended-field radiotherapy beyond the pelvis

Acquired Immune Deficiency Syndrome (AIDS) based upon current CDC definition (however, human immunodeficiency virus [HIV] testing is not required for entry into this protocol)

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

No prior radiation therapy to the pelvis

No prior treatment with platinum-based chemotherapy

Patients may NOT receive amifostine or other protective reagents

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01672892